Those are just a few of the provocative questions being asked now that the device called Aura, tested on patients at Vancouver General Hospital over the past decade, is being offered for sale by the local company that bought the licensing rights.

A North American shortage of dermatologists — caused, in part, by too few being trained and too many doctors opting to do less medical dermatology and more lucrative cosmetic work — is the rationale for putting the device in the hands of family doctors and nurses. It would give them high-tech help in determining which moles and other skin lesions (growths) should be excised and examined (biopsied) by a pathologist.

Virtually all patients diagnosed with melanoma in the earliest stages can be cured. But about 85 per cent of patients diagnosed in the late stages die within five years.

B.C. has about 60 dermatologists and there are job postings for another 24 of the hard-to-fill jobs. There are large regions of the province where there are no dermatologists and patients are waiting twice as long as they should, according to advocacy organizations.

The aging population is expected to increase the prevalence of skin cancers, already the most commonly diagnosed cancers, affecting about 100,000 Canadians annually. Of those skin cancers, melanoma is the least common but the most lethal, accounting for about 6,000 cases of skin cancer in Canada (1,000 in BC) and just over 1,000 deaths (150 in B.C.). Basal and squamous cell carcinomas are the most common types of skin cancers.

The Aura laser light probe, Verisante Technology

Aura could be a useful tool for all types of skin cancers, according to the inventors, doctors who used it during clinical trials and the CEO of the company which is now going to mass-market the device. The advantage of Aura is that it provides an instantaneous result, can be used to quickly scan bodies with dozens of moles and other lesions and is relatively easy to use — which is why it’s promoted as a helpful tool in the shortage-of-dermatologist era.

Thomas Braun, CEO of Verisante Technology which owns the global licensing rights to the Aura device

While the diagnosis of skin cancer has typically been done by a dermatologists’ visual examinations of skin lesions’ shapes, texture, colour, size and other properties, the Aura uses fibre optics and laser light to excite the molecules inside the growths.

The device uses Raman spectroscopy, technology which gets it name from an Indian physicist, Chandrasekhara Venkata Raman, who won the Nobel Prize in Physics in 1930, for his discoveries about the specific fingerprint-like signatures of molecules that are seen when beams of light are used to illuminate the skin.

That allows doctors to analyze the molecules inside the skin growths. A hand-held wand with a disposable tip is connected to a computer that is loaded with software that compares the lesions in question with a database of melanoma and non-melanoma cancers. The probe scans for 21 biomarkers.

Aura is Health Canada approved and it also has approvals in Europe and Australia. Versiante is hoping to gain pivotal U.S. Food and Drug Adminstration approval in a year or two.

In the VGH study, researchers tested an Aura prototype on 453 people with 518 lesions. Subjects were aged 18 to 94. All 44 malignant melanomas, 200 basal cell carcinomas and about 50 squamous cell carcinomas were detected and biopsied. The technology also detected a several hundred benign lesions.

The “when in doubt, cut it out” philosophy is common in dermatology but study authors said the Aura could also help reduce the number of biopsies by at least 50 per cent since it would be a better aid in helping doctors distinguish which skin growths are completely benign and which ones need to be biopsied for further examination.

Numerous studies have shown that doctors could really use another tool in their arsenal. In the BC Cancer Agency study, led by co-inventors/Vancouver dermatologists Harvey Lui and David McLean, previous research is cited, showing that the diagnostic accuracy of melanoma is highly variable — from 49 per cent to 81 per cent.

McLean,whose research on expanded uses for the Aura in other cancers continues, said since doctors are far from perfect in detecting skin cancer, he and his co-researchers set out to find a better method of cancer screening.

We started from the position, can we improve what we see with our naked eyes? What if we look at the molecules inside? We wanted to find something to improve diagnostic ability. Here we are, 15 years later, and our work is coming to fruition.”

McLean, who has retired from daily dermatology practice, but still teaches at UBC medical school and conducts research, said while dermatologists tend to believe they’re exceedingly good at what they do, “we are not as good as we think.

There would be very few physicians who have not had an experience in which melanoma has been missed. It’s a disconcerting event. It does occur and it’s never a happy event.” I’m 66, and any specialist with similar experience that I know couldn’t say they have not missed a diagnosis. Nor would they say they couldn’t use more help.”

While Braun’s goal is to sell at least 100 devices (at about $40,000 each) in the next year, and convince health professionals around the world that they don’t have to be dermatologists to use it, McLean uses more restraint:

Eventually, after we have some real world experience with the Aura, it may be that it is suitable for family doctors and nurse practitioners after they take a day or so of training on it. But right now, I see it as a device that adds value to a dermatology consultation. If a dermatologist thinks something is a cancer, then they should just biopsy it. Where there is a lesion that looks slightly abnormal but doesn’t ring alarm bells, the device can be used as a reinforcement of the decision to biopsy or not. Of course, I have a conflict of interest since I am a co-inventor, but I think it can be used to improve the diagnostic acumen of physicians. It could pick up more melanomas and reduce the number of unnecessary biopsies.”

Previous research that has shown that as many as 58 lesions are scraped or cut away for every one case of melanoma detected.

Verisante placed an Aura prototype with a handful of key dermatologists across Canada over the past year to get their feedback and suggestions for changes to the final model. The Vancouver Sun interviewed two of them, for slightly contrasting perspectives.

In Vancouver, Dr. Jason Rivers, a highly respected skin cancer expert who does both cosmetic and medical dermatology, said he likes the way the device looks at the molecular signature of skin tumours.

“,”type”:”image”,”channels”:[“desktop”,”tablet”,”phone”]}The technology is really interesting and shows a lot of promise but I think we still need to collect more information before it’s unleashed on a lot of physicians.”

Rivers hopes to see a future study, stacking family doctors or dermatologists using Aura against those not using it. Diagnostic accuracy between the groups would be compared.

McLean acknowledges such a study would be ideal “if one could find a granting agency willing to give millions of dollars for that. But that kind of money is usually found only in the patented drug industry,” he said.

Rivers has an eight-month waiting list for his medical (non-cosmetic) patients and given the shortage of dermatologists across the country, he thinks the device could help separate benign lesions from those that are true threats, “freeing up doctors like me to see the most serious cases.”

In the six months that Rivers used the device in his office on about 60 patients, he credits it with detecting one lesion as a melanoma that he had missed. But it did not find a few other melanomas that he detected. In the aforementioned 2012 published study, the device had cancer detection sensitivities of between 95 and 99 per cent — which means it was almost perfect.

Rivers says real-world experience with technology may not mirror what sorts of outcomes occur in research studies. But overall, the Aura is a nice addition to a dermatology practice. He wonders, however, how many doctors will pay $40,000 to buy the device and how many patients will pay for examinations when there is no taxpayer-funded medical system coverage for such examinations anywhere across Canada.

Braun has asked the B.C. Medical Services Commission to allow doctors to bill for examinations with Aura. But that is not likely to happen soon since no government is keen on adding costs to the ballooning health care budget.

Rivers has completed his testing on the Aura and is no longer using it on patients which means that until B.C. doctors purchase the device, the only patients to see it used will be those who go to the Skin Care Centre at VGH where the latest iteration of the device has just been shipped. In Edmonton, dermatologist Dr. Barry Lycka is enthusiastically embracing the technology. He’s used it on 1,000 patients over the past year.

Dr. Barry Lycka, an Edmonton dermatologist using the Aura on a private pay basis

“,”type”:”image”,”channels”:[“desktop”,”tablet”,”phone”]}It’s a very helpful non-invasive tool that has helped me detect five cases of melanoma.” I see a lot of skin cancer patients (300 to 500 per year) and do 20 or 30 biopsies a day. Human beings are fallible; this device helps me determine who really needs a biopsy. You don’t want to be doing them unnecessarily because it can be painful for patients. There’s a wound after a biopsy that needs to heal.”

Lycka received a per patient fee from Verisante during the testing phase (Rivers did not) and now he charges patients $75 to $325 (the latter for whole body skin cancer screening) when he uses the Aura. He says “nobody has balked at paying that.

In an ideal world, everything would be covered by the medicare system but instead we have limitations, so patients are asked to pay for new technology. I think this is a very do-able arrangement for clinics, including family practices, where there are several doctors who take an interest in skin cancer screening and are going to share the device and its costs.”

Braun says it’s possible patients won’t balk at paying for Aura scans because “in dermatology, there is already a culture of paying out-of-pocket for things.”

The fact that Aura, engineered and assembled in Richmond, is a made-in-BC technology that is not yet widely available here frustrates Braun enormously:

The truth is the public owns this technology because taxpayers funded the research but patients here aren’t getting the opportunity to take advantage of it yet.”

The Aura inventors received about $1.5 million in public and private donor-funding over the past 15 years and Braun said when Verisante licensed the rights a few years ago, it gave the BCCA, VGH and UBC certain milestone payments. That included tens of thousands upon licensing, another $100,000 at the time of Health Canada approval and about $500,000 more in research grants. The medical institutions and inventors will eventually get royalties (about six per cent) on each device sale, Braun said.

Dr. Evert Tuyp, a Coquitlam dermatologist who’s head of the BC Medical Association section on dermatology, said he understands Braun’s frustration at the slow adoption of technology, but he’s not yet convinced that Aura will perform better than a dermascope, a tool he currently uses as an adjunct tool to his naked eyes.

A dermatoscope (or dermascope), used by dermatologists for a magnified view of moles and other lesions. Photo credit: Regina Leader-Post

The dermascope (also called dermatoscope) is a simple magnification device which uses polarized light to see into lesions. It is far from perfect and is said to miss about 15 per cent of cancers. On top of that, a study in a dermatology journal a few years ago showed disagreement among pathologists in about 15 per cent of biopsy samples so Tuyp agrees a perfect system of detection does not yet exist.

Tuyp said he paid about $1,200 for the dermascope he’s been using for about six years. Since the government has refused to reimburse doctors for buying and using the device during examinations, they can’t recapture their costs nor can they charge patients for it:

“,”type”:”image”,”channels”:[“desktop”,”tablet”,”phone”]}So if there’s no fee code for dermascopy, do you think there will ever be one for the Aura? Probably when pigs fly is what I would say to that.” So while it’s fascinating technology that makes you say ‘wow’ there are some big issues to overcome here. One is that we need more studies to demonstrate that it will pick up more cancers without more false positives and the other is the tariff issue.”

Braun said he’s spoken to dozens of doctors about the fee issue:

Cancer screening is medically necessary and so many physicians feel uncomfortable asking patients to pay for it. On the other hand, MRI scans are also medically necessary but patients pay for those (at private clinics, on an expedited basis) and you don’t hear too many complaints with that.”

Health minister Terry Lake said he’s received a request from Verisante Technologies for a meeting regarding the Aura skin cancer detection device:

“,”type”:”image”,”channels”:[“desktop”,”tablet”,”phone”]}It’s certainly promising technology. However, we have a responsibility to the taxpayer to provide cost-effective and high quality care. The Ministry of Health has a health technology review process to review non-drug health technologies to determine if any device is appropriate for coverage in B.C. If Verisante can make the case that the device will result in better care for patients and provide better value than current methods, Lake said “it would be something we would seriously consider.”

While Braun talks about Aura being placed in the hands of family doctors and nurses, McLean said he’s reserving judgment on that for now and that all he can promise is that “in the hands of a skilled dermatologist, Aura will add significant value.”

Sam Abraham, BCCA vice-president, strategic relationships, said his office helps scientists patent and commercialize about six to 12 inventions a year. He hopes Verisante sponsors a post-market cost-benefit study:

That’s how you drive these things into the marketplace. Our goal at the BCCA is research and care. Our scientists come up with innovations and then ask the entrepreneurial community to take it from there.”

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